Effectiveness of butylphthalide on cerebral autoregulation in ischemic stroke patients with large artery atherosclerosis (EBCAS study): A randomized, controlled, multicenter trial.
Effectiveness of butylphthalide on cerebral autoregulation in ischemic stroke patients with large artery atherosclerosis (EBCAS study): A randomized, controlled, multicenter trial.
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DOI：
10.1177/0271678x231168507
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发表时间：
2023-10
影响因子：
6.3
通讯作者：
Yang, Yi
中科院分区：
文献类型：
--
作者：
Guo, Zhen-Ni;Yue, Bing-Hong;Fan, Lei;Liu, Jie;Zhu, Yuanyuan;Zhao, Yuanqi;Zhong, Jingxin;Lou, Zhan;Liu, Xing-Liang;Abuduxukuer, Reziya;Zhang, Peng;Qu, Yang;Shen, Ziduo;Shi, Baoyang;Zhang, Ke-Jia;Liu, Jia;Chang, Junlei;Jin, Hang;Sun, Xin;Yang, Yi
寻找合适的药物改善急性缺血性卒中（AIS）患者的脑自动调节（CA）是改善预后的必要条件。我们的目的是研究丁苯酞对AIS患者CA的影响。在这项随机对照试验中，99例患者以2：1的比例随机分配至丁苯酞组或安慰剂组。丁苯酞组接受预先配置的丁苯酞-氯化钠溶液静脉输注14天，口服丁苯酞胶囊76天。安慰剂组同步静脉输注0.9%生理盐水100 mL和口服丁苯酞模拟胶囊。传递函数参数，相位差（PD）和增益被用来量化CA。主要结局是第14天和第90天患侧的CA水平。80例患者完成了随访（丁苯酞组52例，安慰剂组28例）。丁苯酞组14天或出院时和90天时患侧的PD高于安慰剂组。安全性结局的差异不显著。因此，丁苯酞治疗90天可显著改善AIS患者的CA。试用注册：ClinicalTrial.gov：NCT 03413202
Finding appropriate drugs to improve cerebral autoregulation (CA) in patients with acute ischemic stroke (AIS) is necessary to improve prognosis. We aimed to investigate the effect of butylphthalide on CA in patients with AIS. In this randomized controlled trial, 99 patients were 2:1 randomized to butylphthalide or placebo group. The butylphthalide group received intravenous infusion with a preconfigured butylphthalide-sodium chloride solution for 14 days and an oral butylphthalide capsule for additional 76 days. The placebo group synchronously received an intravenous infusion of 100 mL 0.9% saline and an oral butylphthalide simulation capsule. The transfer function parameter, phase difference (PD), and gain were used to quantify CA. The primary outcomes were CA levels on the affected side on day 14 and day 90. Eighty patients completed the follow-up (52 in the butylphthalide group and 28 in the placebo group). The PD of the affected side on 14 days or discharge and on 90 days was higher in the butylphthalide group than in the placebo group. The differences in safety outcomes were not significant. Therefore, butylphthalide treatment for 90 days can significantly improve CA in patients with AIS. Trial registration: ClinicalTrial.gov: NCT03413202
影响因子：
4
作者：
Guo ZN;Sun X;Liu J;Sun H;Zhao Y;Ma H;Xu B;Wang Z;Li C;Yan X;Zhou H;Zhang P;Jin H;Yang Y
通讯作者：
Yang Y